MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA 1.5T; FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET

Model Number	INGENIA 1.5T
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Burning Sensation (2146); Partial thickness (Second Degree) Burn (2694); Skin Burning Sensation (4540)
Date of Event	03/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report involving a patient who underwent a lumbar spine mri in the feet first supine position.The patient was centered slightly lower than lower coastal margins as it was difficult to assess due to the patient's high bmi.It was reported, during the scan, patient complained of burning sensation near the right thigh, the staff went in and placed pads either side to protect them from contact with the bore.Patient said that helped and was happy to continue.The patient's body and bore wall were initially touching and then the pads were placed after the first sequence.During the rest of the scan and right after the scan, the patient did not complain of any further issues.Heating sensation is reported and the burn is reported as a second degree burn with a 3 to 4 cm size blister.The appearance of the blister was more than one hour after the exam.The wound was cleaned and dressed the next day when the patient presented.It is expected the injury will heal completely.The reported burn and blister of 3 to 4 cm meets the criteria for a serious injury.
Additional Manufacturer Narrative
Philips has started an investigation, a follow up report will be submitted once the investigation has been completed.
Additional Manufacturer Narrative
Onsite testing of the system and the coil involved in this case was not carried out.The customer reported the event 18 days after it occurred, rather than in a timely manner.Given this delay, and considering that no further heating incidents were reported thereafter, onsite testing was deemed no longer relevant.The root cause could be clearly determined based on the available information.After our investigation and analysis, there is no indication of a malfunction that could have contributed to the incident.The reported injury, including a second-degree burn and heating sensation near the patient¿s right thigh, most likely occurred due to direct contact or close proximity of the patient¿s body part to the body coil.According to the patient heating questionnaire, it was documented that during the scan, the patient complained of a burning sensation near the right thigh.The staff went in and placed padding on either side to protect the patient from contact with the bore.Patient said that helped and was happy to continue.The patient's body and bore wall were initially touching and then the pads were placed after the first sequence.During the rest of the scan and right after the scan, the patient did not complain of any further issues.Contributing factors to this event is as follows: the patient was obese.The thermoregulation of obese patients is known to be impaired.The risk of rf energy-related injuries is higher in patients with impaired thermoregulation.
Event or Problem Description
Philips received a report involving a patient who underwent a lumbar spine mri in the feet first supine position.The patient was centered slightly lower than lower coastal margins as it was difficult to assess due to the patient's high bmi.It was reported, during the scan, patient complained of burning sensation near the right thigh, the staff went in and placed pads either side to protect them from contact with the bore.Patient said that helped and was happy to continue.The patient's body and bore wall were initially touching and then the pads were placed after the first sequence.During the rest of the scan and right after the scan, the patient did not complain of any further issues.Heating sensation is reported and the burn is reported as a second degree burn with a 3 to 4 cm size blister.The appearance of the blister was more than one hour after the exam.The wound was cleaned and dressed the next day when the patient presented.It is expected the injury will heal completely.The reported burn and blister of 3 to 4 cm meets the criteria for a serious injury.

• Brand Name: INGENIA 1.5T
• Common Device Name: FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: luis casillas lc ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 24910158
• Report Number: 3042177665-2026-000041
• Device Sequence Number: 9195973
• Product Code: LNH
• UDI-Device Identifier: 00884838009820
• UDI-Public: 00884838009820
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: INGENIA 1.5T
• Device Catalogue Number: 781396
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 146 KG